FDA 483 - Ram Precision, Inc. - September 14, 2021

An FDA inspection of Ram Precision Industries in Centerville, OH, identified a significant issue with the firm's complaint handling system. Specifically, procedures for receiving, reviewing, and evaluating customer complaints were not adequately established, leading to a failure to routinely use Complaint Summary Forms as required by their own work instruction. This indicates a deficiency in the firm's quality system regarding complaint management.